DULOXETINE- duloxetine capsule, delayed release pellets

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)

Dostupné s:

Teva Pharmaceuticals USA, Inc.

INN (Mezinárodní Name):

DULOXETINE HYDROCHLORIDE

Složení:

DULOXETINE 20 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Duloxetine delayed-release capsules are indicated for the treatment of: - • Major Depressive Disorder [see Clinical Studies (14.1)] - • Generalized Anxiety Disorder [see Clinical Studies (14.2)] - • Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] - • Chronic Musculoskeletal Pain [see Clinical Studies (14.5)] Monoamine Oxidase Inhibitors (MAOIs) — The use of MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4)]. Starting duloxetine delayed-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of

Přehled produktů:

Duloxetine delayed-release capsules USP are available as follows: 20 mg – a hard gelatin capsule with a light-green cap and light-green body, filled with white to off-white pellets, imprinted on cap with “TEVA” and on body with “7542”, in bottles of 60 (NDC 0093-7542-06). 30 mg – a hard gelatin capsule with a light-blue cap and white body, filled with white to off-white pellets, imprinted on cap with “TEVA” and on body with “7543”, in bottles of 30 (NDC 0093-7543-56) and 90 (NDC 0093-7543-98). 60 mg – a hard gelatin capsule with a light-blue cap and light-green body, filled with white to off-white pellets, imprinted on cap with “TEVA” and on body with “7544”, in bottles of 30 (NDC 0093-7544-56) and 1000 (NDC 0093-7544-10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PELLETS
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Duloxetine Delayed-Release Capsules USP
(doo-LOX-e-teen)
Read this Medication Guide before you start taking duloxetine
delayed-release capsules and each time
you get a refill. There may be new information. This information does
not take the place of talking to
your healthcare provider about your medical condition or treatment.
Talk to your healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression, other
serious mental illnesses, and suicidal thoughts or actions?
•
Duloxetine delayed-release capsules and other antidepressant medicines
may increase suicidal
thoughts or actions in some children, teenagers, or young adults
within the first few months of
treatment or when the dose is changed.
•
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts or
actions. Somepeople may have a particularly high risk of having
suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness).
•
How can I watch for and try to prevent suicidal thoughts and actions?
•
Pay close attention to any changes in mood, behavior, actions,
thoughts, or feelings, especially
sudden changes. This is very important when an antidepressant medicine
is started or when the
dose is changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call your healthcare provider right away if you have any of the
following symptoms or feelings,
especially if they are new, wors

Charakteristika produktu

DULOXETINE- DULOXETINE CAPSULE, DELAYED RELEASE PELLETS
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DULOXETINE DELAYED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DULOXETINE DELAYED-RELEASE
CAPSULES.
DULOXETINE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS (5.1)
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
(5.1)
RECENT MAJOR CHANGES
None.
INDICATIONS AND USAGE
Duloxetine delayed-release capsules are a serotonin and norepinephrine
reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
DOSAGE AND ADMINISTRATION
Take duloxetine delayed-release capsules once daily, with or without
food. Swallow duloxetine delayed-release
capsules whole; do not crush or chew, do not open capsule. Take a
missed dose as soon as it is remembered. Do not
take two doses of duloxetine delayed-release capsules at the same
time. (2)
INDIC ATIO N
STARTING DOSE
TARGET DOSE
MAXIMUM
DO SE
MDD (2.1)
40 mg/day to 60
mg/day
Acute Treatment: 40 mg/day (20 mg twice daily)
to 60 mg/day (once daily or as 30 mg twice daily);
Maintenance Treatment: 60 mg/day
120 mg/day
GAD (2.2)
Adults
Elde rly
Children and Adolescents (7 to 17
years of age)
60 mg/day
30 mg/day
30 mg/day
60 mg/day (once daily)
60 mg/day (once daily)
30 to 60 mg/day (once daily)
120 mg/day
120 mg/day
120 mg/day
DPNP (2.3)
60 mg/day
60 mg/day (once daily)
60 mg/day
Chronic
Musculoske le tal
Pain (2.5)
30 mg/day
60 mg/day (once daily)
60 mg/day
Some patients may benefit from starting at 30 mg once daily (2)
There is no evidence that doses greater than 60 mg/